Gilead Sciences discontinues its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed a clinical hold on it due to a...
Federal Register notice: FDA posts a listing of six information collections that have been approved by OMB.
FDA accepts for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial virus vaccine to adults...
FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic diseases.
Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms approved at the end o...
FDA grants Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to reduce back pain caused by degenerative disc disease.
FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-cell precursor acute l...
FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance of or interruptions ...
